Industry Not Sold On FDA Emerging Technology Program
Complaints Voiced About Cost And Value of Investment
FDA’s calls for more generic industry participation in its Emerging Technology Program fell on deaf ears at a recent meeting, with several complaining about the costs and value of investing in new manufacturing technologies.
You may also be interested in...
Makers of brand pharmaceuticals focused on scope issues and the definition of terms in their comments on the US FDA's draft continuous manufacturing guidance, while makers of generic drugs raised concerns about cost and lack of benefit.
Draft guidance on quality considerations for continuous manufacturing has been published by the US Food and Drug Administration with a 90-day comment period.
FDA reports “growing traction” of continuous manufacturing and a corresponding uptick in the use of models to support this mode of manufacturing. Officials explain how they assess these models during inspections.